Details for New Drug Application (NDA): 212202
✉ Email this page to a colleague
The generic ingredient in ACYCLOVIR is acyclovir sodium. There are fifty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.
Summary for 212202
Tradename: | ACYCLOVIR |
Applicant: | Prinston Inc |
Ingredient: | acyclovir |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 212202
Mechanism of Action | DNA Polymerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 212202
Suppliers and Packaging for NDA: 212202
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACYCLOVIR | acyclovir | OINTMENT;TOPICAL | 212202 | ANDA | Solco Healthcare US, LLC | 43547-499 | 43547-499-41 | 1 TUBE in 1 CARTON (43547-499-41) / 30 g in 1 TUBE |
ACYCLOVIR | acyclovir | OINTMENT;TOPICAL | 212202 | ANDA | Solco Healthcare US, LLC | 43547-499 | 43547-499-42 | 1 TUBE in 1 CARTON (43547-499-42) / 15 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | OINTMENT;TOPICAL | Strength | 5% | ||||
Approval Date: | Nov 15, 2021 | TE: | RLD: | No |
Complete Access Available with Subscription